Last update 03 Apr 2025

Bucelipase alfa

Overview

Basic Info

Drug Type
Enzyme
Synonyms
Bile salt stimulated lipase, BSSL, Exinalda
+ [3]
Target
Action
stimulants
Mechanism
CEL stimulants(carboxyl ester lipase stimulants), Lipase replacements
Active Indication-
Originator Organization
Active Organization-
Drug Highest PhaseDiscontinuedPhase 3
First Approval Date-
Regulation-
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Structure/Sequence

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Exocrine Pancreatic InsufficiencyPhase 3
Europe
02 Aug 2011
Fetal Growth RetardationPhase 3
Belgium
01 May 2011
Fetal Growth RetardationPhase 3
Czechia
01 May 2011
Fetal Growth RetardationPhase 3
France
01 May 2011
Fetal Growth RetardationPhase 3
Germany
01 May 2011
Fetal Growth RetardationPhase 3
Hungary
01 May 2011
Fetal Growth RetardationPhase 3
Italy
01 May 2011
Fetal Growth RetardationPhase 3
Poland
01 May 2011
Fetal Growth RetardationPhase 3
Russia
01 May 2011
Fetal Growth RetardationPhase 3
Spain
01 May 2011
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
415
Recombinant Bile Salt-Stimulated Lipase
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Negative
31 May 2016
Placebo
gmwiaynosp(dcabpkypyn) = agmxfcvneg yanzergoqb (kkunjjqnwr )
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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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